Treatment methods utilizing inflatable dual balloon catheter

ABSTRACT

A dual balloon catheter apparatus for controlling postpartum hemorrhage in uterine or vaginal cavities or hemorrhage in other body cavities, comprising: (1) a catheter having an inflation lumen and a deflation lumen; (2) a first inflatable balloon in fluid communication with the inflation lumen; and (3) a second inflatable balloon encompassing the first balloon and in fluid communication with the deflation lumen. A first fluid inflation medium can be introduced from an external fluid source through the inflation lumen to inflate the first balloon, so as to apply a substantially even pressure along a substantial portion of a uterine cavity to reduce or eliminate bleeding along such inner surface. The second inflatable balloon functions to confine any first fluid inflation medium that escapes (e.g., by leakage or rupture) from the first balloon, and to discharge such medium through the deflation lumen.

STATEMENT OF RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 10/622,275filed on Jul. 18, 2003 and entitled “Inflatable Dual Balloon Catheter.”

FIELD OF THE INVENTION

This invention relates to an inflatable dual balloon catheter, and moreparticularly, to a dual balloon catheter used in conjunction with atamponade device for controlling uterine and vaginal postpartumhemorrhage.

BACKGROUND OF THE INVENTION

Post-partum hemorrhage is most commonly caused by uterine atony wherebythe uterus fails to contract normally after the delivery of a baby. Thiscondition occurs in about 5 percent of deliveries. Hemorrhage continuesto be one of the major causes of maternal deaths generally, withobstetrical hemorrhage being the third leading cause of maternal deathby hemorrhage in the United States. Worldwide, maternal hemorrhagequalifies as the leading cause of maternal death.

Techniques for managing obstetrical hemorrhage may be medical,mechanical, or surgical. Hysterectomy, while an effective surgicalprocedure for treating this condition, bears severe consequences, inparticular for young women who have not completed childbearing.

One of the mechanical procedures often used for managing obstetricalhemorrhage involves packing the uterus with heavy gauze. This procedureremains controversial because of a high failure rate, and is considereda waste of time by some medical practitioners. The high failure rate isattributable to the inherent difficulty in packing the uterus properlyso that there is an even distribution of pressure along the entire innersurface of the organ.

Accordingly, a more effective procedure is needed to address post-partumhemorrhage and bleeding. Ideally, the procedure should present minimallong-term health consequences to the patient, be quickly and easilyaccomplished, be easily learned and require no specializedinstrumentation.

U.S. Patent Application No. US2001/0007945 published on Jul. 12, 2001 toPiraka, the contents of which are hereby incorporated by reference intheir entirety for all purposes, discloses a uterine balloon forcontrolling hemorrhaging in a patient after childbirth. The balloon ofPiraka is filled with a liquid medium, such as water or saline solution,by means of a catheter inserted through a valve in the balloon. A fillsystem, a control system, and a pressure relief valve are each employedfor maintaining a constant solution pressure in the balloon. However,the pressure of the liquid medium is difficult to control and manage,especially when the balloon is only partially filled with such liquidmedium. Further, weight of the liquid medium imposes additional pressureon the lower portion of the vaginal or uterine wall, which intensifiesthe discomfort of the patient during the procedure and may even resultin injury of the soft tissues on the vaginal or uterine wall.

It is therefore an object of the present invention to provide a ballooncatheter for controlling post-partum hemorrhage, with enhanced pressurecontrol and reduced weight.

SUMMARY OF THE INVENTION

The present invention in one aspect relates to a dual balloon catheterthat is inflatable by a gaseous inflation medium. Specifically, suchballoon catheter comprises a first balloon, a second balloon thatencompasses such first balloon, and a catheter having an inflation lumenand a deflation lumen that are separated from each other. The firstballoon is in fluid communication with the inflation lumen of thecatheter, and the second balloon is in fluid communication with thedeflation lumen. After such dual balloon catheter is inserted into abody cavity, a biologically and physiologically compatible gaseousinflation medium, which includes but is not limited to, air, O₂, N₂,Ar₂, CO₂, etc., can be introduced through the inflation lumen to distendthe first balloon inside the body cavity. The inflated first balloonapplies a substantially even pressure along an inner surface of suchbody cavity, therefore reducing or eliminating bleeding alone such innersurface. The second balloon is not inflated but conforms to the contourof the first balloon. In the event that any gaseous inflation mediumescapes from the first balloon, due to either leakage or rapture, suchsecond balloon functions to confine the escaped gaseous medium anddischarge it through the deflation lumen.

Therefore, the risk of gas embolism, which is caused by the entry of gasbubbles into the blood stream through hemorrhage sites and which mayresult in severe injury or even death, is significantly reduced by usingthe dual balloon catheter of the present invention. Moreover, the dualballoon catheter of the present invention, as inflated by a gaseousinflation medium, provides easy, accurate, and quick control of thepressure that is applied to the inner surface of a body cavity thereby.Further, the weight of the gas-inflated balloon of the present inventionis significantly less than that of the liquid-inflated balloon disclosedby Piraka in U.S. Patent Application No. US2001/0007945, thereforesubstantially reducing the discomfort of the patient and avoiding injuryto the soft tissue on the inner surface of the body cavity.

Such dual balloon catheter can be inserted into a body cavity, such asuterine cavity, vaginal cavity, oral cavity, nasal cavity, cranialcavity, vertebral cavity, thoracic cavity, mediastinum, abdominalcavity, etc., for controlling bleeding therein. Alternatively, such dualballoon catheter can be used for dilating blood vessels to treat certaintypes of obstructions or occlusions therein. The contour of the balloonsused depends on the specific shape of the body cavity to which the dualballoon catheter is inserted. For instance, when such dual ballooncatheter is inserted into a uterine cavity, the first and secondballoons are characterized by a heart-shaped contour that conforms tothe inner surface of the uterine cavity; when such dual balloon catheteris inserted into a blood vessel, the first and second balloons arecharacterized by an elongated, tubular contour that conforms to theinner surface of the blood vessel. Conformance of the contour of theballoons with the interior shape of the body cavity enables suchballoons to fit evenly and tightly against the inner surface of the bodycavity, thereby providing pressure against all associated bleedingsites.

Such gas-inflated dual balloon catheter may further comprise adrainage/irrigation lumen in the catheter, which is isolated from theinflation and deflation lumens and which extends beyond the first andsecond balloons. The drainage/irrigation lumen comprises a first openend and a second, opposite open end for draining blood or other bodyfluid from and/or injecting a cleaning or therapeutic fluid into thebody cavity.

Another aspect of the present invention relates to a dual ballooncatheter that is inflatable by a gaseous medium and a liquid medium.Specifically, such balloon catheter comprises a first balloon, a secondballoon that encompasses such first balloon, and a catheter having a gaslumen and a liquid lumen that are separated from each other. The firstballoon is in fluid communication with the gas lumen of the catheter,and the second balloon is in fluid communication with the liquid lumen.After such dual balloon catheter is inserted into a body cavity, abiologically and physiologically compatible gaseous medium, whichincludes but is not limited to air, O₂, N₂, Ar₂, CO₂, etc., can beintroduced through the gas lumen to distend the first balloon, and abiologically and physiologically compatible liquid medium, such as waterand saline solution, can be introduced through the liquid lumen todistend the second balloon. The inflated first and second balloonsjointly apply a substantially even pressure along an inner surface ofsuch body cavity, therefore reducing or eliminating bleeding alone suchinner surface. In the event that any gaseous inflation medium escapesfrom the first balloon, due to either leakage or rapture, such secondballoon functions to confine the escaped gaseous medium therein.

Therefore, the risk of gas embolism, which is caused by the entry of gasbubbles into the blood stream through hemorrhage sites and which mayresult in severe injury or even death, can be significantly reduced byusing such dual balloon catheter of the present invention. Moreover, useof the gaseous medium in inflating the first balloon significantlyreduces the overall weight of the gas/liquid-inflated dual ballooncatheter, and therefore reducing the discomfort of the patient andavoiding injury to the soft tissue on the inner surface of the bodycavity.

A further aspect of the present invention relates to a method ofcontrolling post-partum hemorrhage, by using the gas-inflatable or thegas/liquid-inflatable dual balloon catheter described hereinabove.

Various other aspects, features and embodiments of the invention will bemore fully apparent from the ensuing disclosure and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complex understanding of the invention may be obtained by readingthe following description of specific illustrative embodiments of theinvention in conjunction with the appended drawing in which:

FIG. 1 shows a longitudinal cross-sectional view of a gas-inflated dualballoon catheter apparatus, according to one embodiment of the presentinvention.

FIG. 2 shows a longitudinal cross-sectional view of a gas-inflated dualballoon catheter apparatus having a drainage/irrigation lumen, accordingto one embodiment of the present invention.

FIG. 3 shows a transversal cross-sectional view of the catheter tube ofthe gas-inflated dual balloon catheter apparatus of FIG. 1, along lineA-A.

FIG. 4 shows a transversal cross-sectional view of the catheter tube ofthe gas-inflated dual balloon catheter apparatus of FIG. 3, along lineB-B.

FIGS. 5A and 5B show transversal cross-section views of catheter tubesof gas-inflated dual balloon catheter apparatuses having non-concentricinflation and deflation lumens.

FIGS. 6A and 6B show transversal cross-section views of catheter tubesof gas-inflated dual balloon catheter apparatuses having non-concentricinflation, deflation, and drainage/irrigation lumens.

FIG. 7 shows a longitudinal cross-sectional view of agas/liquid-inflated dual balloon catheter apparatus, according to oneembodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following detailed description includes a description of thepreferred embodiments of the invention presently contemplated. Suchdescription is not intended to be understood in a limiting sense, but tobe an example of the invention presented solely for illustrationthereof, and by reference to which in connection with the followingdescription and the accompanying drawing one skilled in the art may beadvised of the advantages and construction of the invention.

Referring to the FIG. 1, a dual balloon catheter apparatus 10 comprisesa first, inner balloon 18, a second, outer balloon 19, and a catheter12. The catheter has an inflation lumen 14 and a deflation lumen 16 thatare isolated from each other. Opening 14 a of the inflation lumen 14extends beyond opening 16 a of the deflation lumen 16 into the first,inner balloon 18. The first, inner balloon 18 comprises an inflatableportion 18 a and a neck portion 18 b that is leak-tightly engaged withthe catheter at a location that is adjacent to the opening 14 a of theinflation lumen 14. A gaseous inflation medium, such as air, O₂, N₂,Ar₂, CO₂, etc., can be introduced into the first, inner balloon 18 fromthe inflation lumen to distend the first balloon 18. Opening 16 a of thedeflation lumen 16 extends into the second, outer balloon 19, whichcomprises an inflatable portion 19 a and a neck portion 19 b that isleak-tightly engaged with the catheter at a location that is adjacent tothe opening 16 a.

For controlling post-partum hemorrhage, a flat dual balloon catheterapparatus 10 is inserted into the uterine cavity of a patient. A gaseousinflation medium as described hereinabove from an inflation gas sourceis introduced into the first, inner balloon 18 through the inflationlumen 14, so as to distend the first balloon 18 and to apply asubstantially even pressure to a substantial portion of an inner surfaceof the uterine cavity. Such pressure can effectively reduce or eliminatebleeding along such inner surface of the uterine cavity, therefore.

During such process, the second, outer balloon 19 is not inflated, butconforms to the contour of the inflated inner balloon 18 instead. Thefunction of such second, outer balloon 19 is to confine any gaseousinflation medium that escapes from the first, inner balloon 18, due toeither leakage or rapture of such first balloon 18, and to discharge theescaped gaseous inflation medium through the deflation lumen into theatmosphere or a subatmospheric environment (such as a vacuum), thereforereducing the risk of gas embolism caused by entry of gas bubbles intothe blood stream through hemorrhage sites.

The weight of the gas-inflated dual balloon catheter apparatus 10 isminimum, in comparison to the liquid-inflated balloon catheter disclosedby Piraka in U.S. Patent Application No. US2001/0007945, thereforereducing the discomfort of the patient during the treatment process.

The inflation lumen 14 preferably mates with one or more inflationand/or pressure control valves (not shown) for maintaining the innerballoon 18 in an inflated state, and for controllably deflating theinner balloon 18 when it is required that pressure supplied to theuterine cavity be reduced or altogether removed. Such inflation and/orpressure control valves may comprise a variety of conventional devicesincluding, for example, ball valves and needle valves.

The first and the second balloons 18 and 19 are preferably, but notnecessarily, arranged in a substantially concentric relationship, i.e.,the distance between the centers of such first and second balloons areminimum in light of their overall diameters.

The inflation and deflation lumens 14 and 16 of the catheter 12 arepreferably concentric, as shown in FIG. 3, wherein the deflation lumen16 preferably circumscribes the inflation lumen 14. Alternatively, theinflation and deflation lumens of the catheter are not concentric, asshown in FIGS. 5A and 5B. The shape and configuration of the inflationand deflation lumens as shown in FIGS. 3 and 5A-5B are provided only forillustration purposes, and should not be construed to limit the broadscope of the present invention.

Balloons 18 and 19 are made of one or more elastomic or elastoplasticpolymeric materials, such as silicone, urethanes, latex, ethylene vinylacetate (EVA), polyisoprene, styrenic elastomer, polyvinyl chloride,polyamide elastomer, polyester elastomer, polytetrafluoro elastomer,polyamide elastoplastic, polyester elastoplastic, etc., and mixturesthereof. Additional fillers and additives can be provided for enhancingthe properties of such polymeric materials. Balloons 18 and 19 may bemade of the same or different polymeric materials.

Further, an external surface of the inner balloon 18 may be coated witha friction-reducing material, such as a lubricant, to reduce thecoefficient of friction (COF) between such external surface of the innerballoon 18 and an inner surface of the outer balloon 19.

Moreover, an external surface of the outer balloon 19 may preferably becoated, impregnated or otherwise covered with a therapeutic agent, suchas an anti-microbial or a hormone, for delivery thereof, or a hemostaticmaterial, such as oxidized cellulose and hemotene, for contact with theinner surface of the body cavity to further assist in controllingbleeding.

FIG. 2 shows a dual balloon catheter 40 comprising a first, innerballoon 48, a second, outer balloon 49, and a catheter 42. The catheter42 specifically comprises: (1) an inflation lumen 45 having an opening45 a into the first, inner balloon 48, (2) a deflation lumen 46 havingan opening 46 a into the second, outer balloon 49, and (3) adrainage/irrigation lumen 44 that extends beyond the inner and outerballoons 48 and 49. Such drainage/irrigation lumen 44 has a first openend (labeled as “drainage”) and a second, opposite open end 44 a. Whenthe dual balloon catheter 40 is inserted into a body cavity, thedrainage/irrigation lumen functions to drain blood or other body fluidfrom such body cavity, or to inject a cleaning or therapeutic solutioninto such body cavity, for cleansing or treatment thereof.

Both the first and second balloons 48 and 49 comprise an inflatableportion, a first neck portion (left) and a second neck portion (right).The first neck portions (left) of such first and second balloons 48 and49 are leak-tightly engaged with the catheter at respective locations soas to ensure fluid communication of () the first balloon 48 with theinflation lumen 45 and (2) the second balloon 49 with the deflationlumen 46. The second neck portions (right) of such first and secondballoons 48 and 49 are leak-tightly engaged with the catheter at alocation adjacent to the second, opposite open end 44 a of thedrainage/irrigation lumen 44, so that the drainage/irrigation lumen 44opens to the exterior instead of the interior of the first and secondballoons 48 and 49, as shown in FIG. 2.

The inflation, deflation, and drainage/irrigation lumens 44, 45, and 46of the catheter 42 are preferably concentric, as shown in FIG. 4,wherein the deflation lumen 46 preferably circumscribes the inflationlumen 45, which in turn circumscribes the drainage/irrigation lumen 44.Alternatively, the inflation, deflation, and drainage/irrigation lumens44, 45, and 46 of the catheter 42 are not concentric, as shown in FIGS.6A and 6B. The shape and configurations of the inflation, deflation, anddrainage/irrigation lumens as shown in FIGS. 4 and 6A-6B are providedonly for illustration purposes, and should not be construed to limit thebroad scope of the present invention.

The above-described dual balloon catheters 10 and 40 are inflated by agaseous inflation medium, which minimizes the weight of the inflatedballoon catheter and reduces discomfort of the patient caused by theadditional pressure applied to the inner wall of the body cavity by suchweight.

Alternatively, the dual balloon catheter can be partially inflated by agaseous inflation medium, i.e., in the first, inner balloon, and theremaining volume of such dual balloon catheter, i.e., in the second,outer balloon, can be inflated by a liquid inflation medium such aswater or saline solution. Use of the gaseous inflation mediumsubstantially reduces the overall weight of the inflated ballooncatheter, in comparison with that of a balloon catheter that iscompletely inflated by a liquid, while at the same time, the liquidinflation medium can be used to heat or cool the inner surface of thebody cavity for treatment thereof.

FIG. 7 shows a gas/liquid-inflated dual balloon catheter apparatus 60that is similar to the gas-inflated dual balloon catheter 10 of FIG. 1,except that the catheter 62 of such apparatus 60 comprises (1) a gaslumen 64 that opens into the first, inner balloon 68, for inflating suchinner balloon 68 with a gaseous inflation medium, and (2) a liquid lumen66 that opens into the second, outer balloon 69, for inflating suchouter balloon 69 with a liquid inflation medium.

The volumetric ratio between the inner and outer balloons 68 and 69(i.e., the volumetric ratio between gas and liquid medium) is preferablyin a range of from about 1:1 to about 1000:1.

Such gas/liquid-inflated dual balloon catheter apparatus 60 may furthercomprise a drainage/irrigation lumen (not shown) circumvented by the gaslumen 64 and liquid lumen 66, which extends beyond the first and secondballoons 68 and 69 for draining body fluids from, or injecting cleaningor therapeutic solutions into, the body cavity.

The gas-inflated or gas/liquid-inflated dual balloon catheter apparatusof the present invention may be simply operated by inserting suchapparatus to a desired position in a body cavity such as a uterinecavity, and inflating the first, inner balloon and/or the second, outerballoon to a desired pressure and volume. Optimum pressure is detected,for example, when there is no further fluid drainage. After anappropriate length of time, pressure can be lowered and observationsmade to determine whether or not bleeding has been controlled. Ifbleeding begins again, the balloon may be reinflated.

While the present invention has been described at some length and withsome particularity with respect to the several described embodiments, itis not intended that it should be limited to any such particulars orembodiments or any particular embodiment, but it is to be construed withreferences to the appended claims so as to provide the broadest possibleinterpretation of such claims in view of the prior art and, therefore,to effectively encompass the intended scope of the invention.

1. A method for controlling post-partum hemorrhage, comprising:providing a balloon catheter apparatus comprising: a catheter having atleast two lumens that are isolated from each other, one of which beingan inflation lumen, and the other of which being a deflation lumen; afirst balloon having an inflatable portion and at least one neckportion, wherein said first balloon is in fluid communication with theinflation lumen, so that a fluid inflation medium can be introduced intosaid first balloon through the inflation lumen; and a second balloonencompassing said first balloon, wherein said second balloon has aninflatable portion and at least one neck portion, and wherein saidsecond balloon is in fluid communication with the deflation lumen, sothat any fluid inflation medium in said second balloon can be dischargedfrom said second balloon through the deflation lumen; wherein at leastone of the first balloon and the second balloon comprises an elastomicor elastoplastic polymeric material; inserting the balloon catheterapparatus into at least one of an internal uterine wall area and avaginal wall area; and inflating the first balloon with a first fluidinflation medium so as to apply a substantially even pressure over theat least one wall area for reducing or eliminating bleeding therein. 2.The method of claim 1, wherein said elastomic or elastoplastic materialcomprises any of any of: silicone, urethane, latex, ethylene vinylacetate (EVA), polyisoprene, styrenic elastomer, polyvinyl chloride,polyamide elastomer, polyester elastomer, polytetrafluoro elastomer,polyamide elastoplastic, and polyester elastoplastic.
 3. The method ofclaim 1, wherein the second balloon is coated with a hemostatic materialadapted to moderate or reduce hemorrhage of the at least one wall area.4. The method of claim 1, wherein the hemostatic material comprisesoxidized cellulose.
 5. The method of claim 1, wherein the hemostaticmaterial comprises hemotene.
 6. The method of claim 1, wherein at leasta portion of each of the first balloon and the second balloon is shapedto conform to the inner surface of a uterine cavity.
 7. The method ofclaim 1, wherein at least a portion of each of the first balloon and thesecond balloon is substantially heart-shaped.
 8. The method of claim 1,further comprising inflating the second balloon with a second fluidinflation medium.
 9. The method of claim 8, further comprising heatingthe second fluid inflation medium.
 10. The method of claim 8, furthercomprising cooling the second fluid inflation medium.
 11. The method ofclaim 10, further comprising controllably deflating any of the firstballoon and the second balloon.
 12. The method of claim 1, wherein theballoon catheter apparatus further includes a drainage/irrigation lumen,and the method further comprises any of: (a) extracting draining bodyfluid from any of a uterine area and a vaginal area, (b) supplyingcleaning fluid into any of a uterine area and a vaginal area, and (c)supplying therapeutic fluid into any of a uterine area and a vaginalarea.